HAI-Related Litigation: What Infection Preventionists Need to Know

Kelly M. Pyrek, Infection Control Today
12/18/2009

Litigation related to healthcare-acquired infections (HAIs) is a trend that should be on every infection preventionist (IP)’s radar for the coming decade, especially in light of the fact that the frequency of hospital professional liability claims is increasing. According to a new study released by Aon Corporation in conjunction with the American Society for Healthcare Risk Management, these claims are on the rise and are expected to continue increasing at a 1 percent annual rate.

The study, the 10th annual Hospital Professional Liability and Physician Liability Benchmark Analysis, examines trends in frequency, severity and overall loss costs related to hospital and physician professional liability; 100-plus healthcare organizations representing more than 1,500 facilities ranging from small community hospitals to large multi-state healthcare systems provided loss and exposure data for the study. The study attributes the rise in claims to the downturn in the U.S. economy, changes to the Centers for Medicare and Medicaid Services (CMS) reimbursement rules regarding so called “never-events” and changes in public sympathy toward healthcare providers.

“Worsening economic conditions in 2008 may have influenced individuals to assert claims against hospital systems,” says Erik Johnson, healthcare practice leader for Aon’s Actuarial and Analytics Practice and author of the analysis. “From 2003 through 2007 public attention was directed on tort reform activity and prohibitive medical malpractice costs for physicians. This coincided with significant reductions in professional liability claims. As public attention shifted to other subjects, the momentum of the reductions dissipated. Recently, the public focus has evolved to discussions regarding waste, inefficiency and defensive medicine. It remains to be seen how this will influence the frequency of professional liability claims.”

The study also found that 1 out of every 4 claims and 24 percent of hospital professional liability costs are associated with hospital-acquired conditions such as infections and injuries, medication errors, retained objects during surgery and pressure ulcers. Juries may be starting to take notice of this trend; Hsieh (2009) reports that recently, a jury in Suffolk County, New York awarded $13.5 million to a 40-year-old woman who died of a flesh-eating bacteria that she contracted during chemotherapy treatment at Dana-Farber Cancer Institute. Hsieh (2009) also quotes Gloria Seidule, an attorney at Seidule & Webber, as noting, “Anyone providing healthcare to an individual is no longer going to have immunity for transmitting infections.” Seidule is also litigating a hospital-acquired infection lawsuit involving methicillin-resistant Staphylococcus aureus (MRSA). Hsieh (2009) also reports that Mary Coffey, an attorney at Coffey Nichols, recently won a $2.58 million verdict for a 69-year-old man who contracted MRSA through an IV that was administered in the ambulance following a heart attack. When doctors inserted a pacemaker, the infection spread, ultimately resulting in the loss of a kidney and a leg.

During the “Changing Legal and Regulatory Landscape” conference sponsored by the Association for Professionals in Infection Control and Epidemiology (APIC) held in November, a panel of experts addressed the legal issues surrounding HAIs. Panelist Russell Nassof, director of strategic initiatives at TRC, says, “Changes in the regulatory environment, reimbursement practices and legal standards along with drastic changes in healthcare itself are creating a potential ‘perfect storm’ of liability and increase risk for healthcare-associated infections in healthcare facilities today.”

Nassof notes that events that were previously thought of as risks are now considered to be preventable adverse events, and that IPs will play an even bigger role in protecting their hospitals against liability in the future. At issue is the increased transparency created within the healthcare system in general, which also triggered public reporting of infection rates data. Currently, just a handful of states do not have or have not considered adopting legislation mandating public reporting, and a federal bill related to MRSA is under consideration. According to Nassof, state hospital associations have opposed these reporting requirements due to fear of increased exposure to liability, issues related to reporting logistics, efficiency issues such as diverting resources from patient care and/or prevention efforts; and conflicting reporting requirements such as infection site and organism.

There are unanswered legal questions that are in this complicated mix, according to Nassof, and they include whether or not prescreening for infections such as those caused by MRSA is a Pandora’s box or a solid legal defense. Another wrinkle is the fact that CMS is currently not paying the differential related to hospital-acquired infections and conditions (as of Oct. 1, 2008, Medicare has stopped reimbursing for certain types of hospital-acquired infections; see related article on page 18), and Nassof says the door is open for CMS to cease payment completely for certain infections and conditions, and requiring hospitals to conduct root cause analyses or to apologize to patients and their families. “It’s a tricky legal situation,” Nassof says. “Can a facility apologize and still defend a claim before a jury?”

While the burden has always been on the plaintiff, Nassof says a recent case in the U.S. had the burden of proof shifting to the hospital, which had to prove that the patient did not get the infection at its facility. “There is the perception that there is potential negligence on the part of hospitals for not protecting patients. A strict liability standard has not been applied to HAIs... yet,” Nassof says. “Hospitals must develop legally defensible protocols and best practices, train staff to follow them, and document that they are being done.” Nassof advises IPs to don their legal hats because infection rate data that IPs collect could be damaging to the hospital and/or be used against it in a lawsuit.

APIC conference panelist Emily Rhinehart, RN, MPH, CIC, CPHQ, vice president of healthcare risk consulting for Chartis Insurance, says that at the present, HAI-related lawsuits are “few and far between but the legal landscape is changing.” She recommends that hospitals stick with evidence-based practices and carefully document in the patient’s medical record any departures from these protocols. “You can’t make it up when you are defending a case, so documentation is key,” Rhinehart says. She also recommends that expectations for patient care be made unambiguous, that compliance is ensured through the use of checklists and other tools, and that the entire process is monitored and documented. A good example is hand hygiene, Rhinehart says. “There is a strong public perception of the lack of hand hygiene in hospitals. The plaintiff could be perplexed by it and pursue a case.”

To that end, panelist Nicholas McConnell, director of the law firm Jackson & Campbell PC, added that most healthcare-related lawsuits are not about the quality of care but rather the atmosphere at the healthcare institution, and how healthcare providers present the clinical actions that were taken. “The hospital must explain why a particular outcome was allowed to happen, and so the imperative here is the standard of care, which can be found in the hospital’s own policies and procedures,” McConnell says. “At the heart of the case is did anyone depart from that standard of care? The proof is simple if the compliance is clearly lacking. And did that departure cause harm to the patient?” McConnell explains that while the law admires excellence, it does not demand it; however, a departure from the standard of care is a significant challenge to defend.